This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your firm’s product labeling and your website at www.hcgcompletediet.com. Based on our review, “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” are unapproved new drugs in violation of sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331 and 355] and are misbranded in violation of sections 503 and 301 of the Act [21 U.S.C. §§ 353 and 331].

“By following the hCG diet, the excess fat is mobilized for energy and the rest is eliminated.”

“Most hCG dieters have reported a loss of one to two pounds a day.”

“They help you to not feel as hungry during the first week on the 500 calorie portion of the diet. They also help prepare your body to target the fat cells for weight loss.”

We recognize that a number of pages on your website contain a disclaimer stating that the products should not be used to diagnose, treat, cure, or prevent any disease. However, notwithstanding this disclaimer, the claims made on your websites for “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” clearly demonstrate that these products are drugs as defined by section 201(g)(1) of the Act

[21 U.S.C. § 321(g)(1)], because they are intended to affect the structure or any function of the body.

Further, “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” are “new drugs” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for these intended uses.

Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. There are no FDA-approved applications on file for the above products. Therefore, the marketing of “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” without approved applications constitutes a violation of these provisions of the Act.

We recognize that labeling identifies these products as homeopathic drugs. The definition of “drug” in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. The CPG defines a homeopathic drug as: “Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.”

According to your website, “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” contain human chorionic gonadotropin (HCG). HCG is not an established homeopathic active ingredients included in the HPUS or any of the addenda or supplements. Furthermore, to our knowledge, HCG is not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, HCG is not considered a homeopathic drug ingredient and “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” are not considered homeopathic drug products under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula.”

[21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] provides that a drug which “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug” shall be dispensed only upon a prescription by a practitioner licensed by law to administer such drug. Your labeling provides that your products should be taken in conjunction with a very low calorie diet (VLCD). A VLCD should only be used under proper medical supervision. Because they are subject to section 503(b)(1) of the Act, “Alcohol Free hCG Weight Loss Formula,” “hCG Diet Pellets Weight Loss Formula,” and “hCG Diet Drops Weight Loss Formula” are misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that their labels fail to bear the symbol, "Rx only."[1] Your marketing of these misbranded products violates sections 301(a) and (k) of the Act [21 U.S.C. §§ 331(a) and (k)].

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

We note that under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321 (ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505, which was not marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Pregnyl, which contains HCG as the active ingredient, as a new drug on October 20, 1976. To FDA's knowledge there is no evidence that HCG was marketed as a dietary supplement or food prior to FDA approval of Pregnyl. As such, a product containing HCG could not be a dietary supplement.

In addition, we have the following comment: Your firm’s website, www.hcgcompletediet.com, makes use of the FDA logo. The FDA logo is for the official use of FDA and not for the use of the private sector. To the public, such use would send a message that FDA favors or endorses an organization, its activities, its products, its services, and/or its personnel which it does not and cannot do. Misuse of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.Furthermore, please advise this office of what actions you will take to address product that you have already distributed.

Your reply should be directed to the attention of Ms. Nancy Schmidt, Compliance Officer, at P.O. Box 25087, Denver, CO 80225-0087. If you have questions regarding any issue in this letter, please contact Ms. Schmidt at (303) 236-3046.

FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or an Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at healthproducts@ftc.gov, within fifteen working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Richard Cleland at (202) 326-3088.

Sincerely,

/S/

LaTonya M. Mitchell, District Director

Denver District Office

Food and Drug Administration

/S/

Mary K. Engle, Associate Director

Division of Advertising Practices

Federal Trade Commission

/S/

Ilisa B.G. Bernstein, Pharm.D., J.D.

Acting Director, Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

cc:

Mr. Tom Hall, Registered Agent

www.hcgcompletediet.com

4228 W. Mesquite Way

Cedar Hills, UT 84062

www.hcgcompletediet.com

55 Merchant Street #621

American Fork, UT 84003

(b)(4)

[1] The Agency’s guidance, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15),” states that, in accordance with § 503(b)(1) of the Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription.” This guidance was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the Act to require that the label of a prescription drug must bear the symbol “Rx only.”